Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,207
- 试验地点
- 2
- 主要终点
- To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post).
研究概览
简要总结
System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).
The investigators propose a 3-arm cluster randomized controlled trial that will analyze the implementation process and compare the cost and effectiveness of three implementation strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the investigators will identify multi-level factors that facilitate or impede the implementation process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential determinant of patient cessation outcomes. Our secondary outcome will be post-intervention patient-reported quit rates. In addition to examining the comparative effectiveness of the three implementation strategies, the investigators will use a mixed methods approach to examine implementation processes (Aim 2) to assess the degree to which the interventions are integrated into practice as intended and to clarify the mechanisms through which the intervention influences provider behavior.
详细描述
Purpose of the Study System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).
Staff Training and Clinical Reminder Systems. The PHS Guideline strongly recommends staff training, clinical reminder systems and other practice supports as the foundation for treating tobacco dependence in health care settings. Despite observed limitations (Curry 2008, Grimshaw 2003, Shelley 2010), staff training, practice supports, clinical reminder systems and referral pathways represent current best practices (CBP) for screening and treating tobacco dependence.
Performance Feedback (PF). In recent randomized trials conducted in primary medical care settings, clinical audit and feedback with regard to tobacco treatment performance have been associated with a twofold increase in cessation assistance and referral to cessation quitlines (Bentz 2007, Curry 2008, Wadland 2007). While clinical audit and feedback have been shown to increase provider adherence to tobacco use treatment guidelines in medical settings, these strategies have not yet been examined in dental practice (Curry 2000, Curry 2008, Fiore 2007, Fiore 2008, Grimshaw 2006, Solberg 2000).
Pay for Performance (P4P). P4P or providing financial incentives for meeting predetermined performance goals has attracted much interest as a strategy to improving guideline implementation and the quality of care (Petersen 2006, Sonnad, 1998). The recent consensus report from the 2nd European Workshop on Tobacco use Prevention and Cessation for Oral Health Professionals emphasized the importance of appropriate compensation of tobacco use treatment to provide incentive to oral health providers (Ramseier 2010). Several studies have demonstrated a positive association between P4P and adherence to recommended tobacco use treatment (An 2008, Coleman, 2010, Roski, 2003). For instance, An et al, found that a P4P program increased referrals to statewide tobacco quitline services (An 2008). Electronic dental records and automated billing systems (such as the Dentrix system used by most of our participating dental clinic sites) are adding nicotine dependence diagnostic and treatment procedure codes. This health informatics trend bodes well for the sustainability of performance feedback and P4P implementation strategies.
Background Based on meta-analyses of over 8000 tobacco cessation studies published in the past three decades, the 2008 Public Health Service (PHS) Guideline, Treating Tobacco Use and Dependence provides strong evidence that provider delivery of tobacco dependence treatment, including cessation pharmacotherapy and brief counseling, can produce significant and sustained reductions in tobacco use and should be delivered to all smokers seeking routine health care (Fiore 2008). Provider adherence to the PHS Guideline recommendations requires Asking all patients about tobacco use, Advising smokers to quit, Assessing readiness to quit, providing cessation Assistance and Arranging follow-up (5As) (Fiore 2008). Adequate implementation of the PHS Guidelines would generate 1.6 million additional quitters per year and nearly 3.3 million quality life years saved (USDHHS 2000).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinics are included if they are located within the NYC metropolitan area and employ at least three FTE dentists.
- •Providers are included if they practice full-time or part-time at one of the study clinics
- •Patients are included if they are 18 years or older, active smokers defined as those who report smoking cigarettes some days, most days, or every day and have smoked in the past 7 days, have an appointment with a dentist or hygienist, NYS resident, speak English, Spanish, Chinese or Russian, and are able to comply with study procedures in the opinion of the principal investigator.
排除标准
- •Clinic locations are excluded if the number of unique adult patient visits per week averages less than 100, if the dental director reports that the clinic assists more than 60% of patients with tobacco cessation and if the clinics policies would prohibit the clinic from accepting pay-for-performance funds if randomized to that arm. All sites with less than 3 dental providers will also be excluded.
- •Providers are excluded if they do not speak English.
- •Patients are excluded if they do not speak English, Spanish, Chinese or Russian, and if they have already completed the patient exit interview during the same intervention phase.
研究组 & 干预措施
CBP + PF
Field sites randomly assigned to Arm 2 will receive as an intervention current best practices and quarterly audits and performance feedback reports (PF) on provider delivery of cessation services using chart audit procedures that we have used successfully in prior work. Depending on what is used at the site, paper or Electronic Dental Record, we will work with the site to create a registry of patients who are tobacco users.
干预措施: Audit and performance feedback (PF) (Behavioral)
CBP + PF
Field sites randomly assigned to Arm 2 will receive as an intervention current best practices and quarterly audits and performance feedback reports (PF) on provider delivery of cessation services using chart audit procedures that we have used successfully in prior work. Depending on what is used at the site, paper or Electronic Dental Record, we will work with the site to create a registry of patients who are tobacco users.
干预措施: Current Best Practices (CBP) (Behavioral)
CBP + PF + P4P
Field sites randomly assigned to this implementation condition (Arm 3) will receive current best practices (CBP), quarterly audit and performance feedback reports (PF), and financial incentives (pay for performance, P4P) for every documented (documentation in patient chart of counseling, prescription, or referral to the quit-line) delivery of adherence to clinical practice guidelines.
干预措施: Financial Incentive (P4P) (Behavioral)
CBP + PF + P4P
Field sites randomly assigned to this implementation condition (Arm 3) will receive current best practices (CBP), quarterly audit and performance feedback reports (PF), and financial incentives (pay for performance, P4P) for every documented (documentation in patient chart of counseling, prescription, or referral to the quit-line) delivery of adherence to clinical practice guidelines.
干预措施: Current Best Practices (CBP) (Behavioral)
CBP + PF + P4P
Field sites randomly assigned to this implementation condition (Arm 3) will receive current best practices (CBP), quarterly audit and performance feedback reports (PF), and financial incentives (pay for performance, P4P) for every documented (documentation in patient chart of counseling, prescription, or referral to the quit-line) delivery of adherence to clinical practice guidelines.
干预措施: Audit and performance feedback (PF) (Behavioral)
Current Best Practices (CBP)
All dental field sites will receive current best practices (CBP) for training and technical assistance in promoting adoption of clinical practice guidelines for treating tobacco dependence.
干预措施: Current Best Practices (CBP) (Behavioral)
结局指标
主要结局
To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post).
时间窗: prior to and approximately 12 months following each site's enrollment in the study
The Patient Exit Interview (PEI) is a brief patient-reported measurement tool for the assessment of provider delivery of tobacco use treatment. Patients will be approached during their clinic visits by trained research study assistants, to determine smoking status and to obtain consent. Patient eligibility includes: 1) age 18 or over; and 2) active smokers defined as those who report smoking within the past 7 days.
Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation
时间窗: June 2013-June 2017
We will also conduct provider surveys with all participating dentists and dental directors, and focus groups with all participating dental providers, dental directors and other key informants, including stakeholders in administrative and technical roles before and after the intervention. For the provider surveys, we will be asking all the dental providers (dental directors, dentists, dental hygienists, dental residents) to complete the surveys. We expect to enroll approximately 30 providers at each site for a total of 540 providers for the provider surveys. The number of participating dentists from each site will vary depending upon the size of the dental practice.
次要结局
- Cost analysis(last two years of the study/ end of each site's enrollment period)
- assess patient utilization of cessation services and smoking abstinence(0-6 months post intervention phase)
